Introduction

To support its research mission Yale University (Yale) enters into a variety of research collaborations or affiliations with other organizations. When these collaborations or affiliations involve a non-Yale organization that is “engaged in [human subjects] research” (as defined by the U.S. Department of Health & Human Services (DHHS), Office for Human Research Protections (OHRP)), Yale will, under certain circumstances and with appropriate documentation, agree to serve as the organization’s Institutional Review Board (IRB) of record. The IRB review process contributes to the ethical conduct of research that involves human volunteers and is required by federal regulation.

Click here for a list of the external organizations for which Yale has agreed to serve as the organization's IRB.

What is a Yale Research Affiliate?

In the context of human subjects research, a Yale Research Affiliate (RA) is an organization for which Yale has agreed to serve as the IRB of record. An organization that is approved as an RA is permitted to submit its proposed research protocols to a Yale IRB for review. In some cases, Yale’s agreement to serve as the IRB of record will extend over a number of years and cover many research studies. In other cases, the agreement will apply only to one research study. A Yale researcher will normally be required to be the principal investigator on the research protocol(s).

Who should read this website?

This website describes the requirements for becoming a Yale RA, the RA application and approval processes, and the required RA documentation. This website will assist potential RAs (administrators, researchers, and support staff) and Yale researchers who plan to conduct human subjects research in which an external organization will be "engaged."

What are the requirements and the process to become a Yale RA?

An organization must demonstrate that it adheres to principles of ethical conduct of research and federal regulations before Yale will agree to serve as an organization's IRB of record. The potential RA will be asked to submit an application that will describe, among other things, the organization's mission, the proposed research, the organization's human subjects protections policies, and the organization's human subjects training.

The application process to become a Yale RA has several steps:

1. The Yale principal investigator who plans to work with the potential RA must contact the Yale IRB most likely to review the proposed research protocol to determine if an RA relationship is appropriate. Certain types of research affiliations or collaborations require different types of documentation.
2. The Yale principal investigator and the potential RA should review this website to familiarize themselves with the requirements.
3. The potential RA must:
   1. Create and adopt (or review and, if appropriate, revise its existing) written policies (http://irb.yale.edu/forms/) that define the organization's standards of conduct in research involving human subjects.
   2. Designate a Signatory Official and Human Protections Administrator.
   3. Complete all required training.
   4. Prepare a draft Federalwide Assurance (FWA) to submit to Yale for review.
   5. Complete an RA Application and submit it to the cognizant IRB for Yale review.
4. Yale University will review and approve or disapprove the RA application.
5. If the application is approved, the organization and Yale must sign an IRB Authorization Agreement (IAA) that designates one or more Yale IRB(s) as the organization's IRB(s) of record; and
6. After the IAA has been signed, the organization must submit its FWA to OHRP for approval. A potential RA should not submit its FWA to OHRP until Yale has signed the IAA.

For more detailed information on the application process, see The Application Process. An organization that wishes to submit an RA application should review this website and follow the instructions provided.

This website was made possible by grant number 2 S07 RR 18252-02 from the National Center for Research Resources (NIH). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NCRR or NIH.